Status:
RECRUITING
Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures
Lead Sponsor:
Hospital Universitario La Fe
Conditions:
Coronary Artery Disease
Bleeding
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous c...
Detailed Description
The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures. Because of the exploratory n...
Eligibility Criteria
Inclusion
- Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 25% of the population undergoing PCI will be included.
Exclusion
- Aged \< 18 years
- Cardiogenic shock
- Major active bleeding at the time of the procedure
- Use of mechanical circulatory support
- Chronic total occlusions
- Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar)
- Inability to provide informed consent
- Unable to understand and follow study-related instructions or unable to comply with study protocol
- Currently participating in another trial
- Pregnant women
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 20 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05292846
Start Date
January 20 2022
End Date
April 20 2024
Last Update
January 26 2024
Active Locations (4)
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1
Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
2
Hospital del Mar
Barcelona, Spain
3
Hospital La Paz
Madrid, Spain
4
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026